Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B

• Sponsor: Taichung Veterans General Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03933384
• Collaborator: (none)
• Enrollment: 420
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 76.4
• Patients Per Site Per Month: 5.5

Study Details

Study Description

Brief Summary

To compare the efficacy and renal safety of tenofovir alafenamide (TAF) versus entecavir (ETV) in the chronic hepatitis B patients.

Condition or Disease	Intervention/Treatment	Phase
Hepatitis B; Viral Hepatitis	Drug: Tenofovir alafenamide; Drug: Entecavir	Phase 4

Detailed Description

With high antiviral potency and low drug resistance rate, both ETV and tenofovir disoproxil fumarate (TDF) have been recommended as the first-line antiviral therapy for chronic hepatitis B (CHB). However, risk of renal dysfunction remains an issue in TDF long-term therapy. Tenofovir alafenamide (TAF) is a novel prodrug of tenofovir and is formulated to deliver the active metabolite to target cells more efficiently than TDF at lower doses, thereby reducing systemic exposure to tenofovir. Importantly, TAF had improved renal safety as compared to TDF. TAF has been approved for treating CHB since 2017; however, it is still unknown whether the efficacy and renal safety of TAF is compatible to those of ETV. The investigators aim to conduct an open label, randomized controlled trial comparing TAF with ETV for assessing their efficacy and renal safety in CHB patients. The eligible CHB patients are randomly assigned (1:1) to receive TAF or ETV. After allocation to TAF group or ETV group, study subjects will receive therapy for 3 years (144 weeks).

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 420 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: The eligible chronic hepatitis B patients are randomly assigned (1:1) to receive once-daily oral doses of tenofovir alafenamide 25 mg or entecavir 0.5mg.The eligible chronic hepatitis B patients are randomly assigned (1:1) to receive once-daily oral doses of tenofovir alafenamide 25 mg or entecavir 0.5mg.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Tenofovir Alafenamide Versus Entecavir for the Treatment of Chronic Hepatitis B: An Open Label, Randomized Controlled Trial
• Actual Study Start Date: Aug 19, 2019
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tenofovir alafenamide group Study subjects will receive tenofovir alafenamide 25 mg/tab once daily for 3 years (144 weeks).	Drug: Tenofovir alafenamide; Tenofovir alafenamide 25mg/tab once daily; Other Names: Vemlidy
Active Comparator: Entecavir group Study subjects will receive entecavir 0.5 mg/tab once daily for 3 years (144 weeks).	Drug: Entecavir; Entecavir 0.5mg/tab once daily; Other Names: Baraclude

Outcome Measures

Primary Outcome Measures

1. HBV viral suppression [After 48-week therapy of Tenofovir alafenamide or entecavir]

   proportion of patients with hepatitis B virus(HBV) -DNA suppression

2. Renal safety: Change of estimated glomerular filtration rate [After 48-week therapy of Tenofovir alafenamide or entecavir]

   Change of estimated glomerular filtration rate

Secondary Outcome Measures

1. Normalization alanine aminotransferase (ALT) [After 48-week therapy of Tenofovir alafenamide or entecavir]

   proportion of patients with ALT normalization

2. HBsAg loss [After 48-week therapy of Tenofovir alafenamide or entecavir]

   proportion of patients with HBsAg loss

3. HBeAg loss [After 48-week therapy of Tenofovir alafenamide or entecavir]

   proportion of patients with HBeAg loss

4. Bone mineral density [After 48-week therapy of Tenofovir alafenamide or entecavir]

   change of bone mineral density

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients more than 20 years old

2. Chronic hepatitis B patients

3. Patients who were indicated for hepatitis B virus antiviral therapy

Exclusion Criteria:

1. Decompensated liver disease (Child-Pugh B &C)

2. End stage renal disease (eGRF < 15 ml/min/1.73m2)

3. Prior use of nucleot(s)ide analogues for chronic hepatitis B

4. Prior use of interferon for chronic hepatitis B within six months

5. Known history of human immunodeficiency virus or hepatitis C virus co-infection

6. Concurrent other uncontrolled malignancy

7. Women in pregnancy or lactation

8. Cannot conform to the study protocol of this study

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taichung Veterans General Hospital	Taichung		Taiwan

Sponsors and Collaborators

• Taichung Veterans General Hospital

Investigators

• Study Chair: Teng-Yu Lee, MD, PhD, Taichung Veterans General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Teng-Yu Lee, Principal Investigator, Taichung Veterans General Hospital
• ClinicalTrials.gov Identifier: NCT03933384
• Other Study ID Numbers: CF18341A; 106DHA0500150
• First Posted: May 1, 2019
• Last Update Posted: Feb 10, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Keywords provided by Teng-Yu Lee, Principal Investigator, Taichung Veterans General Hospital: Hepatitis B; Viral Hepatitis; Tenofovir alafenamide; Entecavir
• Additional relevant MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Tenofovir; Entecavir

Study Results

No Results Posted as of Feb 10, 2022